Virtual Reality Games in Pediatric Surgery

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Surgical Procedure, Unspecified; Immersion; Analgesia

Treatments: Other: Virtual reality gaming; Drug: Nitrous oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT05510141

2020-01446

Details and patient eligibility

About

Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using virtual reality gaming (VR) compared to nitrous oxide. Therefore, 50 patients in each treatment group are recruited, resulting in 100 children altogether. The pain levels and pain control/reduction is measured by the standard anesthesia protocol normally used when nitrous oxide is applied and questionnaires that are administered to the patients at baseline and two weeks after surgery including both the primary and secondary outcome.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
• Written informed consent by parents
• Written informed consent by patient if patient is 14 or 15 years old

Exclusion criteria

• Inability to understand the VR-program
• Inability to fill in the questionnaire because of language deficiencies
• Neurologic disorders
• Respiratory tract infections
• Intolerance of the VR headset or VR gaming procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual Reality Gaming

Experimental group

Treatment:

Other: Virtual reality gaming

Nitrous Oxide

Active Comparator group

Description:

Standard procedure

Treatment:

Drug: Nitrous oxide